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The European Commission approval of this expanded indication for PEGINTRONand REBETOL results in Marketing Authorization with unified labeling that isvalid in the current EU 27 member states as well as in Iceland and Norway.
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"This approval is an option for the large number of hepatitis C patientswho failed prior therapy because it gives them a second chance at success,"said Nadine Piorkowsky, president of the European Liver Patient Association(ELPA). "These patients want to eradicate the virus and now can determineafter 12 weeks of retreatment with PEGINTRON combination therapy whether theyare likely to go on to achieve a sustained response with a 48-week course oftherapy."
The approval is based on results from an ongoing non-comparative clinicalstudy (EPIC3)(1) in which 1,336 patients with moderate to severe fibrosis orcirrhosis who failed previous treatment with combination alphainterferon/ribavirin therapy were retreated with PEGINTRON combinationtherapy. In this study, virological response at week 12 of treatment wasshown to be an important predictor for achieving a sustained virologicalresponse (SVR), with 57 percent of patients who had undetectable virus (HCV-RNA) at week 12 going on to achieve SVR with a 48-week course of therapy.Within this subgroup, the SVR rates were 59 percent and 47 percent forpatients who failed prior therapy with non-pegylated or pegylated interferon,respectively.
Approximately 37 percent of patients in the study overall had undetectablevirus at week 12. Importantly, patients who achieved a significant reductionin virus (greater than 2 log decrease) but did not have undetectable virus atweek 12, had little chance of achieving SVR (6 percent). Overall, 23 percentof patients in the study achieved SVR, including 16 percent of patients whofailed prior peginterferon and ribavirin combination therapy. SVR is definedas undetectable HCV-RNA at 24 weeks post-treatment.
"Based on a patient's treatment history, these PEGINTRON data allowphysicians to identify which patients in this hard-to-treat population areright for retreatment and are most likely to achieve a sustained response,"said Thierry Poynard, M.D., professor of medicine, University of Paris VI,Hopital Pitie-Salpetriere, Paris, and a lead investigator of the EPIC study."The predictability of response with PEGINTRON means patients withundetectable virus at week 12 have an even chance of success regardless ofwhether they failed previous therapy with pegylated or non-pegylatedinterferon and can be motivated to continue treatment, and those patients whofail to achieve an early response can have their therapy stopped withconfidence."
In the study, failure to prior therapy was defined as relapse ornonresponse to one or more courses of interferon alpha plus ribavirincombination therapy (HCV-RNA positive at the end of a minimum of 12 weeks oftreatment). Patients who were HCV-RNA negative at treatment week 12 continuedtreatment for a total of 48 weeks and were followed for 24 weeks post-treatment.
Based on results from the EPIC3 study, the recommended duration of dosingwith PEGINTRON combination therapy for retreating patients who failed previousth
